Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?

August 5, 2022 updated by: AGUSTINA VENDRAMINI, Hospital Italiano de Buenos Aires
According to International Urogynecological Association and International Continence Society joint report on the terminology for female pelvic floor dysfunction, overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. Bladder training lasting for a minimum of 4 to 6 weeks is indicated as a first-line treatment. The investigators' goal is to compare changes in satisfaction, measured in terms of quality of life, in 2 groups of women with different main accompanying symptoms in OAB (frequency vs. nocturia), before and after bladder training utilizing telemedicine (virtual bladder training), for 4 to 6 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women over 18 years of age
  • Live in Buenos Aires City
  • Overactive Bladder Syndrome
  • Access to virtual appointment

Exclusion Criteria:

  • Previous overactive bladder syndrome treatment.
  • Prior stress urinary incontinence or pelvic organ prolapse surgery.
  • History of Neurogenic Bladder, pelvic organs prolapse or pelvic radiation.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Frequency
Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman.
Other: Bladder training
Bladder training for overactive bladder syndrome.
OTHER: Nocturia
Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate.
Other: Bladder training
Bladder training for overactive bladder syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in King's Health Questionnaire (KHQ) score
Time Frame: Change from Baseline King's Health Questionnaire at 6 weeks
KHQ score: 0-100 points per domain. Higher scores mean a worse outcome.Ten points change in KHQ score, before and after bladder training.
Change from Baseline King's Health Questionnaire at 6 weeks
Change in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score
Time Frame: Change from Baseline International Consultation on Incontinence Questionnaire Short Form at 6 weeks
ICIQ SF score: 0-21 points. Higher scores mean a worse outcome. Three points change in ICIQ-SF score, before and after bladder training.
Change from Baseline International Consultation on Incontinence Questionnaire Short Form at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2022

Primary Completion (ANTICIPATED)

October 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (ACTUAL)

August 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • # 6237 PRIISA 6017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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